The U.S Food and Drug Administration (FDA) released warnings about some of the recently recalled HeartStart automated external defibrillator devices manufactured by Philips Medical Systems.
The Automated external defibrillator (AED) is an automatic device that performs heart beat analysis and sends electrical shock to cardiac arrest victims to revive them and bring back their pulse rate to normal. When they function well, AEDs are very critical in saving people who have heart attacks.
Around 300,000 Americans experience cardiac arrest every year. And when a sudden attack is not given attention quickly by attempting to restore the heart's rhythm to normal rate, there is a high possibility that the victim will die.
The recalled AED devices, known as HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite, were released by Philips Healthcare within the period 2005 to 2012. These devices, which count to an estimated 700,000 units, were recalled due to an inner electrical component malfunction.
In November 19, Philips issued a Medical Device Safety Notice which informed consumers about the possible failure of the AEDS in sending electrical shocks to cardiac arrest victims. The notice also requested the users to check their Maintenance Advisory disclaimer icon.
The FDA released its warning advisory which provided recommended steps to examine, check, and use their devices.
"If the device indicates it has detected an error during a self-test the FDA advises users to keep recalled HeartStart AEDs in service until a replacement from Philips Healthcare or another AED manufacturer is obtained. Despite current manufacturing and performance problems, the FDA considers the benefits of attempting to use an AED in a cardiac arrest emergency greater than the risk of not attempting to use the defibrillator," said FDA Office of Compliance Director Steve Silverman in a press release.
In the meantime, the FDA continues its vigilant monitoring manufacturing practices and quality standards of AED manufacturers to make sure that these devices work properly and serve their function well.
